System, Image Processing, Radiological

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Recent recalls

• 2026-08-26Open, ClassifiedSoftware design

  FUJIFILM Synapse PACS software v7.4.310; radiological image processing system

  Software issue may cause the ruler measurement to be inaccurate.

• 2026-08-21Open, ClassifiedSoftware Design Change

  Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation

  Software issue may cause measurements to be displayed inaccurately.

• 2026-08-04Open, ClassifiedSoftware Design Change

  Merge PACS, medical imaging diagnostic workstation

  Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.

• 2026-08-04Open, ClassifiedSoftware Design Change

  Merge OrthoPACS, medical imaging diagnostic workstation

  Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient study is open.

• 2026-07-22Open, ClassifiedDevice Design

  Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.

  Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.

• 2026-06-24Open, ClassifiedSoftware design

  GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System

  GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment.

• 2026-05-06Open, ClassifiedUnder Investigation by firm

  Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.;

  If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients.

• 2026-04-10Open, ClassifiedLabeling design

  Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

  Potential safety issue involving the Mean Aneurysm Flow Amplitude (MAFA) ratio of AneurysmFlow (Interventional Tool). Philips has determined that the MAFA ratio does not provide reliable prognostic information regarding aneurysm occlusion following Flow Diverter Stent treatment, however despite being stated in the IUF, it is being relied on for making clinical decisions.

• 2026-03-27Open, ClassifiedSoftware design

  Vue Motion V12. Product Number: 1017979.

  Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.

• 2026-03-16Open, ClassifiedSoftware design

  Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 5826659-029, 5826659-032, 5826659-033, 5826659-028, 5826659-034, 5826659-030, 5826659-019, 5826659-022, 5826659-026, 5826659-023, 5826659-031, 5826659-025, 5826659-002, 5826659-021, 5826659-037, 5826659-014, 5826659-016, 5826659-013

  There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.